HaemodialysisNCT07655544

Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters

A study testing Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) in people with Haemodialysis and Haemodialysis Complication, run by Medical University of Vienna at 1 site in Austria.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Haemodialysis, Haemodialysis Complication, Vascular Access
What is being tested?: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteAustria
Study dates: 1 Aug 2026to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients aged greater than 18 years
Written informed consent
Requirement for hemodialysis using a tunneled dialysis catheter

Who cannot join

Children aged less than 18 years
Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein [CRP >5 mg/dl (normal <0.5 mg/dl)] at screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gürkan Sengölge, Assoc. Prof contact

+43 1 40400 43890

guerkan.sengoelge@meduniwien.ac.at

Austria1 site

Medical University of Vienna
Vienna
Gürkan Sengölge, Assoc. Prof., +43 1 40400-43890, guerkan.sengoelge@meduniwien.ac.at

Other trials in Austria

About this study

Official title: Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study

There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.

Conditions: Haemodialysis, Haemodialysis Complication, Vascular Access, Vascular Access Complication, ESRD (End Stage Renal Disease), Dialysis Access Dysfunction
Being tested: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)Device
In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.

Study groups in NCT07655544
Study group	Role	What they receive
Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment	Active comparator	Study participants will be recruited among those patients with the need of insertion of a tunneled catheter to perform hemodialysis who attend the recruitment site (Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis) for routine care. A tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be implanted. As a standard catheter lock solution 4% citrate (applied in each of the 2 lumens after each dialysis session) will be used. Care of the tunneled catheter in the study sites will be followed established standards including dressing changes, exit site care and hygiene. After each hemodialysis session the exit site will be inspected and covered with 2.0% chlorhexidine dressing (Tegaderm CHG, 3M, Neuss, Germany). Chronic haemodialyisis treatment will be held in a regular setting based on the patient's dialysis requirements. Receives: Device: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Catheter dysfunction
Catheter dysfunction will be defined as inadequate blood flow during dialysis (blood flow < 200mL/min or >30% less than the average of the previous 10 sessions) and if present before or during dialysis, patient repositioning or reversal of catheter lines will be performed. If not successful, Taurolock Urokinase with a final Urokinase of 50.000 IU will be instilled per lumen either with a 30-minute dwell time before dialysis or as CLS in the inter-dialytic time as rescue. If urokinase is not effective after repeated use the dialysis catheter will be removed.
Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (11)

Need for reversal of catheter lines
Measured: From enrollment to the end of treatment at 6 months
Rescue with high dose urokinase (50.000 IU per lumen)
Measured: From enrollment to the end of treatment at 6 months
Total number of catheter-related infections
Catheter-related infections will be defined as positive bacterial blood culture drawn from the dialysis catheter in a symptomatic patient with fever or chills associated with dialysis and no apparent other source of infection. Blood cultures will be taken using aseptic technique from each lumen of the tunneled catheter and in addition from a peripheral vein whenever possible to determine the differential time to positivity.
Measured: From enrollment to the end of treatment at 6 months
Catheter-related infections free survival
Measured: From enrollment to the end of treatment at 6 months
Episodes of antibiotic therapy
Measured: From enrollment to the end of treatment at 6 months
Hospitalization days for catheter-related infectious event
Measured: From enrollment to the end of treatment at 6 months
Hospitalization for all-cause infectious event
Measured: From enrollment to the end of treatment at 6 months
Catheter removal due to infectious and mechanical complication
Measured: From enrollment to the end of treatment at 6 months
Exit-site or tunnel infection
Exit site infections will be defined as culturepositive inflammation localized to the exit site, not extending above the cuff. Tunnel infection is defined as culture-positive inflammation within the catheter tunnel internal to the cuff
Measured: From enrollment to the end of treatment at 6 months
Catheter renewal
Measured: From enrollment to the end of treatment at 6 months
Determine whether Endexo® catheters demonstrate biofilm formation
Explanted catheters (distal tip, intraluminal segments) will be sent to MoKi Analytics GmbH for assessment of biofilm formation using fluorescence in situ hybridization (FISH) according to validated SOPs.
Measured: From enrollment to the end of treatment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202631 Dec 2027

First posted18 Jun 2026
Study start1 Aug 2026 (estimated)
Primary completion1 Aug 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HaemodialysisStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07655544
Sponsor's protocol ID: 1987/2025
Status last verified: Mar 2026
First submitted: 11 Jun 2026
Last updated: 18 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Winnicki W, Herkner H, Lorenz M, Handisurya A, Kikic Z, Bielesz B, Schairer B, Reiter T, Eskandary F, Sunder-Plassmann G, Sengoelge G. Taurolidine-based catheter lock regimen significantly reduces overall costs, infection, and dysfunction rates of tunneled hemodialysis catheters. Kidney Int. 2018 Mar;93(3):753-760. doi: 10.1016/j.kint.2017.06.026. Epub 2017 Sep 8.
PubMed 28890326
Kleidon T, Ullman AJ, Zhang L, Mihala G, Chaseling B, Schoutrop J, Rickard CM. How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics. J Hosp Med. 2018 Aug 1;13(8):517-525. doi: 10.12788/jhm.2911. Epub 2018 Feb 8.
PubMed 29649341
El Khudari H, Ozen M, Kowalczyk B, Bassuner J, Almehmi A. Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications. Semin Intervent Radiol. 2022 Feb 18;39(1):90-102. doi: 10.1055/s-0042-1742346. eCollection 2022 Feb.
PubMed 35210738
Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007.
PubMed 11128425

Interested in taking part?

Gürkan Sengölge, Assoc. Prof

+43 1 40400 43890

guerkan.sengoelge@meduniwien.ac.at

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Haemodialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study
ClinicalTrials.gov ID: NCT07655544
Acronym / sponsor ID: 1987/2025
Conditions: Haemodialysis, Haemodialysis Complication, Vascular Access, Vascular Access Complication, ESRD (End Stage Renal Disease), Dialysis Access Dysfunction
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: 1 Aug 2026 (estimated)
Primary completion: 1 Aug 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 18 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment	Active comparator	Device: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)Study participants will be recruited among those patients with the need of insertion of a tunneled catheter to perform hemodialysis who attend the recruitment site (Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis) for routine care. A tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be implanted. As a standard catheter lock solution 4% citrate (applied in each of the 2 lumens after each dialysis session) will be used. Care of the tunneled catheter in the study sites will be followed established standards including dressing changes, exit site care and hygiene. After each hemodialysis session the exit site will be inspected and covered with 2.0% chlorhexidine dressing (Tegaderm CHG, 3M, Neuss, Germany). Chronic haemodialyisis treatment will be held in a regular setting based on the patient's dialysis requirements.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients aged greater than 18 years
Written informed consent
Requirement for hemodialysis using a tunneled dialysis catheter

Key exclusion criteria (2 listed)

Children aged less than 18 years
Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein [CRP >5 mg/dl (normal <0.5 mg/dl)] at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.	Device	Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment

Primary outcome

Catheter dysfunction
Time frame: From enrollment to the end of treatment at 6 months
Catheter dysfunction will be defined as inadequate blood flow during dialysis (blood flow < 200mL/min or >30% less than the average of the previous 10 sessions) and if present before or during dialysis, patient repositioning or reversal of catheter lines will be performed. If not successful, Taurolock Urokinase with a final Urokinase of 50.000 IU will be instilled per lumen either with a 30-minute dwell time before dialysis or as CLS in the inter-dialytic time as rescue. If urokinase is not effective after repeated use the dialysis catheter will be removed.

11 secondary outcomes

Need for reversal of catheter lines
Time frame: From enrollment to the end of treatment at 6 months
Rescue with high dose urokinase (50.000 IU per lumen)
Time frame: From enrollment to the end of treatment at 6 months
Total number of catheter-related infections
Time frame: From enrollment to the end of treatment at 6 months
Catheter-related infections free survival
Time frame: From enrollment to the end of treatment at 6 months
Episodes of antibiotic therapy
Time frame: From enrollment to the end of treatment at 6 months
Hospitalization days for catheter-related infectious event
Time frame: From enrollment to the end of treatment at 6 months
Hospitalization for all-cause infectious event
Time frame: From enrollment to the end of treatment at 6 months
Catheter removal due to infectious and mechanical complication
Time frame: From enrollment to the end of treatment at 6 months
Exit-site or tunnel infection
Time frame: From enrollment to the end of treatment at 6 months
Catheter renewal
Time frame: From enrollment to the end of treatment at 6 months
Determine whether Endexo® catheters demonstrate biofilm formation
Time frame: From enrollment to the end of treatment at 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Background: PubMed 28890326Winnicki W, Herkner H, Lorenz M, Handisurya A, Kikic Z, Bielesz B, Schairer B, Reiter T, Eskandary F, Sunder-Plassmann G, Sengoelge G. Taurolidine-based catheter lock regimen significantly reduces overall costs, infection, and dysfunction rates of tunneled hemodialysis catheters. Kidney Int. 2018 Mar;93(3):753-760. doi: 10.1016/j.kint.2017.06.026. Epub 2017 Sep 8.
Background: PubMed 29649341Kleidon T, Ullman AJ, Zhang L, Mihala G, Chaseling B, Schoutrop J, Rickard CM. How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics. J Hosp Med. 2018 Aug 1;13(8):517-525. doi: 10.12788/jhm.2911. Epub 2018 Feb 8.
Background: PubMed 35210738El Khudari H, Ozen M, Kowalczyk B, Bassuner J, Almehmi A. Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications. Semin Intervent Radiol. 2022 Feb 18;39(1):90-102. doi: 10.1055/s-0042-1742346. eCollection 2022 Feb.
Background: PubMed 11128425Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007.
Individual participant dataSharing planned: Undecided

Related trials for Haemodialysis

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
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RecruitingPhase 1
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Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
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Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Gürkan Sengölge, Assoc. Prof contact

+43 1 40400 43890

guerkan.sengoelge@meduniwien.ac.at

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gürkan Sengölge, Assoc. Prof (+43 1 40400 43890, guerkan.sengoelge@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Catheter dysfunction (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07655544, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.